# FDA 483 - Intas Pharmaceuticals Limited - August 02, 2019

Source: https://www.globalkeysolutions.net/records/483/intas-pharmaceuticals-limited/d8b8b922-c242-4064-89d5-38ff992edec5

> FDA 483 for Intas Pharmaceuticals Limited on August 02, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intas Pharmaceuticals Limited
- Inspection Date: 2019-08-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Intas Pharmaceuticals Limited in Ahmedabad, Gujarat, India, was inspected by the FDA from July 22 to August 2, 2019. The inspection revealed significant deficiencies across multiple areas, including inadequate validation of aseptic and sterilization processes, unsuitable testing methods, failures in cleaning validation, and environmental control issues. These observations indicate a lack of robust quality control and assurance systems for sterile drug product manufacturing.

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## Related Officers

- [Compliance Officer](https://www.globalkeysolutions.net/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)
- [Thomas J. Arista](https://www.globalkeysolutions.net/people/thomas-j-arista/37905892-3285-4f3f-b4b5-f963df1e59d3)
- [Rita Kabaso](https://www.globalkeysolutions.net/people/rita-kabaso/a8383d6d-b945-4edc-97a4-90944574835d)

Company: https://www.globalkeysolutions.net/companies/intas-pharmaceuticals-limited/0db00702-d7f6-4a8b-87d1-1b32ac236cc8

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1